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In this critical role, you will be responsible for leading and executing Process Performance Qualification (PPQ) activities in accordance with global quality standards and applicable regulatory requirements.
Duties
Author, review, and execute PPQ protocols and reports in alignment with the client's global standards and regulatory expectations.
Define PPQ strategy including batch numbers, sampling plans, acceptance criteria, and statistical approaches.
Contribute to the development and maintenance of the Process Validation Master Plan (PVMP).
Support lifecycle management changes requiring PPQ, including technology transfers and post-approval changes.
Develop / Participate in risk assessments to evaluate process risks and define appropriate control strategies.
Apply risk-based approaches to PPQ study design, sampling strategies, and acceptance criteria justification.
Ensure timely closure of PPQ-related deviations and CAPAs prior to and following PPQ execution.
Maintain accurate and audit-ready documentation throughout the validation lifecycle.
Work closely with MSAT, Manufacturing Operations, Quality Control, and Quality Assurance to ensure alignment on PPQ strategy, execution, and outcomes.
Ensure all PPQ activities are conducted in compliance with applicable regulations and guidelines.
Support regulatory inspections and internal audits by providing PPQ documentation and technical expertise. xcfaprz
Provide training and technical guidance to operations personnel, validation associates, and cross-functional team members involved in PPQ activities.
Design and execute Continued Process Verification (CPV) programs
Qualifications and Experience
Degree in science (e.g. Chemistry, Microbiology or IT preferred) or Engineering (Chemical/Mech/Elec) discipline
Minimum 3–5 years of experience in pharmaceutical manufacturing, process validation, or quality assurance in a regulated GMP environment
Demonstrated hands‑on experience in Process Performance Qualification (PPQ) design, execution, and reporting
Proven track record of authoring and reviewing validation documentation (protocols, reports, deviations, change controls)
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Sprachkenntnisse
- English
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